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NOT YET RECRUITING
NCT07863557
PHASE4

E-Type - Early Wear of Polyethylene Liners Used in DMC

Sponsor: Uppsala University

View on ClinicalTrials.gov

Summary

This is a single-centre, randomized, double-blinded controlled non-inferiority trial that will be conducted at the Orthopaedic Department at Uppsala University Hospital, Uppsala. The aim of the study is to evaluate the performance of a dual mobility acetabular component with a Vitamin E-infused highly crosslinked polyethylene (VEPE) liner compared to a conventional polyethylene (PE) liner in adult patients with symptomatic osteoarthritis, osteonecrosis, or dysplasia of the hip requiring a hip replacement. The assessments will focus on early wear, cup migration, adverse events, and clinical outcomes. Measurements will be conducted using Computed Tomography Radiostereometric Analysis (CT-RSA) instead of traditional radiostereometric analysis. The study hypothesis is that the PE liner will be non-inferior to the VEPE liner in terms of early wear over a two-year period.

Official title: Early Wear Patterns Detected With CT RSA in Vitamin E-infused Liner Versus Conventional Highly Crosslinked Liner After Total Hip Arthroplasty With Dual Mobility Cups: a Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-10-02

Completion Date

2033-10-01

Last Updated

2026-10-07

Healthy Volunteers

No

Interventions

DEVICE

Total Hip Arthroplasty

All patients will be operated with an anterolateral or posterior approach using a cemented or uncemented cup (BiMobile, Waldemar Link GmbH, Hamburg, Germany).

Locations (1)

Uppsala University Hospital

Uppsala, Uppsala County, Sweden